Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - xagrid

Document Subject

Generated Narrative: MedicinalProductDefinition mp872cd13279fdc0dc1dd808e9546511e4

identifier: http://ema.europa.eu/identifier/EU/1/04/295/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Xagrid 0.5 mg hard capsules.

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-872cd13279fdc0dc1dd808e9546511e4

identifier: http://ema.europa.eu/identifier/EU/1/04/295/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - xagrid

Attesters

What is in this leaflet:

1. What Xagrid is and what it is used for
2. What you need to know before you take Xagrid
3. How to take Xagrid
4. Possible side effects
5. How to store Xagrid
6. Contents of the pack and other information

Xagrid contains the active substance, anagrelide. Xagrid is a medicine which interferes with the development of platelets. It reduces the number of platelets produced by the bone marrow, which results in a decrease in the platelet count in the blood towards a more normal level. For this reason, it is used to treat patients with essential thrombocythaemia. Essential thrombocythaemia is a condition which occurs when the bone marrow produces too many of the blood cells known as platelets. Large numbers of platelets in the blood can cause serious problems with blood circulation and clotting.

Do not take Xagrid

If you are allergic to anagrelide or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recognised as a rash, itching, swollen face or lips, or shortness of breath;

If you have moderate or severe liver problems;

If you have moderate or severe kidney problems. Warnings and precautions Talk to your doctor before taking Xagrid:

If you have or think you might have a problem with your heart;

If you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), or you are taking other medicines that result in abnormal ECG changes or if you have low levels of electrolytes e.g., potassium, magnesium or calcium (see section Other medicines and Xagrid );

If you have any problems with your liver or kidneys. In combination with acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting, also known as aspirin), there is an increased risk of major haemorrhages (bleeding) (see section Other medicines and Xagrid ). While taking Xagrid, you should take the exact dose prescribed by your doctor. Do not stop taking the medicine without first talking to your doctor. Do not abruptly stop taking this medicine without consulting your doctor. Abrupt withdrawal of medicine may lead to increased risk of stroke. Signs and symptoms of stroke may include sudden numbness or weakness in the face, arm, or leg, especially on one side of the body, sudden confusion, trouble speaking, or difficulty understanding speech, sudden trouble seeing in one or both eyes, sudden trouble walking, dizziness, loss of balance, or lack of coordination and sudden severe headache with no known cause. Please seek immediate medical help. Children and adolescents There is limited information on the use of Xagrid in children and adolescents and therefore this medicine should be used with caution. Other medicines and Xagrid Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. Tell your doctor if you are taking any of the following medicines:

Medicines that can alter your heart rhythm e.g., sotalol, amiodarone;

Fluvoxamine, used to treat depression;

Certain types of antibiotic, such as enoxacin, used to treat infections;

Theophylline, used to treat severe asthma and breathing problems;

Medicines used to treat heart disorders, for example, milrinone, enoximone, amrinone, olprinone and cilostazol;

Acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting, also known as aspirin);

Other medicines used to treat conditions affecting the platelets in your blood, e.g., clopidogrel;

Omeprazole, used to reduce the amount of acid produced in the stomach;

Oral contraceptives: If you experience bad diarrhoea whilst taking this medicine, it may reduce how well the oral contraceptive works and use of an extra method of contraception is recommended (e.g., condom). See the instructions in the patient leaflet of the contraceptive pill you are taking. Xagrid or these medicines may not work properly if taken together. If you are not sure, speak to your doctor or pharmacist for advice. Pregnancy and breast-feeding Tell your doctor if you are pregnant or are planning to become pregnant. Xagrid should not be taken by pregnant women. Women who are at risk of becoming pregnant should make sure that they are using effective contraception when taking Xagrid. Speak to your doctor if you need advice with contraception. Tell your doctor if you are breast-feeding or if you are planning to breast-feed your baby. Xagrid should not be taken while breast-feeding. You must stop breast-feeding if you are taking Xagrid. Driving and using machines Dizziness has been reported by some patients taking Xagrid. Do not drive or use machines if you feel dizzy. Xagrid contains lactose Lactose is an ingredient in this medicine. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Always take Xagrid exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The amount of Xagrid that people take can be different, and this depends on your condition. Your doctor will prescribe the best dose for you. The usual starting dose of Xagrid is 1 mg. You take this dose as one capsule of 0.5 mg twice a day, for at least a week. After this time, your doctor may either increase or decrease the number of capsules that you take to find the dose best suited to you and which treats your condition most effectively. Your capsules should be swallowed whole with a glass of water. Do not crush the capsules or dilute the contents in a liquid. You can take the capsules with food or after a meal or on an empty stomach. It is best to take the capsule(s) at the same time every day. Do not take more or less capsules than your doctor has recommended. Do not stop taking the medicine without first talking to your doctor. You should not suddenly stop taking this medicine on your own. Your doctor will ask you to have blood tests at regular intervals to check that your medicine is working effectively and that your liver and kidneys are working well. If you take more Xagrid than you should If you take more Xagrid than you should or if someone else has taken your medicine, tell a doctor or pharmacist immediately. Show them the pack of Xagrid. If you forget to take Xagrid Take your capsules as soon as you remember. Take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

Like all medicines, Xagrid can cause side effects, although not everybody gets them. If you are worried, speak to your doctor. Serious side effects: Uncommon: Heart failure (signs include shortness of breath, chest pain, swelling of the legs due to fluid build-up), severe problem with the rate or rhythm of the heartbeat (ventricular tachycardia, supraventricular tachycardia or atrial fibrillation), inflammation of the pancreas which causes severe abdominal and back pain (pancreatitis), vomiting blood or passing bloody or black stools, severe reduction in blood cells which can cause weakness, bruising, bleeding or infections (pancytopenia), pulmonary hypertension (signs include shortness of breath, swelling in legs or ankles, and lips and skin can turn bluish colour). Rare: Kidney failure (when you pass little or no urine), heart attack. If you notice any of these side effects, contact your doctor immediately. Very common side effects: may affect more than 1 in 10 people Headache. Common side effects: may affect up to 1 in 10 people Dizziness, tiredness, rapid heartbeat, irregular or strong heartbeat (palpitations), feeling sick (nausea), diarrhoea, stomach pain, wind, being sick (vomiting), reduction in red blood cell count (anaemia), fluid retention or rash. Uncommon side effects: may affect up to 1 in 100 people A feeling of weakness or feeling unwell, high blood pressure, irregular heartbeat, fainting, chills or fever, indigestion, loss of appetite, constipation, bruising, bleeding, swelling (oedema), weight loss, muscle aches, painful joints, back pain, decreased or loss of feeling or sensation such as numbness, especially in the skin, abnormal feeling or sensation such as tingling and pins and needles , sleeplessness, depression, confusion, nervousness, dry mouth, loss of memory, breathlessness, nosebleed, serious lung infection with fever, shortness of breath, cough, phlegm; hair loss, skin itching or discolouration, impotence, chest pain, reduction in blood platelets, which increases the risk of bleeding or bruising (thrombocytopenia), accumulation of fluid around the lungs or an increase in liver enzymes. Your doctor may do a blood test which may show an increase in your liver enzymes. Rare side effects: may affect up to 1 in 1,000 people Bleeding gums, weight gain, severe chest pain (angina pectoris), heart muscle disease, (signs include fatigue, chest pain and palpitations), enlarged heart, accumulation of fluid around the heart, painful spasm of the blood vessels on the heart (while resting, usually at night or early morning) (Prinzmetal angina), loss of coordination, difficulty in speaking, dry skin, migraine, visual disturbances or double vision, ringing in the ears, dizziness on standing up (especially when getting up from a sitting or lying position), increased need to pass water at night, pain, flu-like symptoms, sleepiness, widening of blood vessels, inflammation of the large bowel (signs include: diarrhoea, usually with blood and mucus, stomach pain, fever), inflammation of the stomach (signs include: pain, nausea, vomiting), area of abnormal density in the lung, increased creatinine level in blood tests, which may be a sign of kidney problems. The following side effects have been reported but it is not known exactly how often they occur:

Potentially life-threatening, irregular heartbeat (Torsade de pointes);

Inflammation of the liver, symptoms include nausea, vomiting, itching, yellowing of the skin and eyes, discoloration of stool and urine (hepatitis);

Lung inflammation (signs include fever, coughing, difficulty breathing, wheezing; which causes scaring of the lungs) (allergic alveolitis, including interstitial lung disease, pneumonitis);

Inflammation of the kidneys (tubulointerstitial nephritis).

Stroke (see section 2). Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. If your doctor stops your medicine, do not keep any leftover capsules unless your doctor tells you to. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Xagrid contains The active substance is anagrelide. Each capsule contains 0.5 mg anagrelide (as anagrelide hydrochloride). The other ingredients are: Capsule contents: povidone (E1201); crospovidone; lactose, anhydrous; lactose monohydrate; cellulose, microcrystalline (E460) and magnesium stearate. Capsule shell: gelatin and titanium dioxide (E171). Printing ink: shellac; strong ammonium solution; potassium hydroxide (E525); black iron oxide (E172). What Xagrid looks like and contents of the pack Xagrid is supplied as opaque, white, hard capsules. They are marked with S 063 . The capsules are provided in bottles containing 100 hard capsules. The bottle also contains a small sealed container. This contains a drying agent to keep the capsules dry. Keep the sealed container in the bottle. Do not remove or eat the drying agent. Marketing Authorisation Holder and Manufacturer Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 58 Baggot Street Lower Dublin 2 D02 HWIreland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Takeda Belgium NV T l/Tel: +32 2 464 06 medinfoEMEA@takeda.com Lietuva Takeda, UAB Tel: +370 521 09 medinfoEMEA@takeda.com

.: +359 2 958 27 Luxembourg/Luxemburg Takeda Belgium NV T l/Tel: +32 2 464 06 medinfoEMEA@takeda.com medinfoEMEA@takeda.com esk republika Takeda Pharmaceuticals Czech Republic s.r.o. Tel: +420 234 722 medinfoEMEA@takeda.com Magyarorsz g Takeda Pharma Kft. Tel.: +36 1 270 7medinfoEMEA@takeda.com Danmark Takeda Pharma A/S Tlf: +45 46 77 10 medinfoEMEA@takeda.com Malta Drugsales Ltd Tel: +356 21419safety@drugsalesltd.com Deutschland Takeda GmbH Tel: +49 (0)800 825 3medinfoEMEA@takeda.com Nederland Takeda Nederland B.V. Tel: +31 20 203 5medinfoEMEA@takeda.com Eesti Takeda Pharma AS Tel: +372 6177 medinfoEMEA@takeda.com Norge Takeda AS Tlf: +47 800 800 medinfoEMEA@takeda.com

akeda . . T : +30 210 6387medinfoEMEA@takeda.com sterreich Takeda Pharma Ges.m.b.H. Tel: +43 (0) 800-20 80 medinfoEMEA@takeda.com Espa a Takeda Farmac utica Espa a S.A Tel: +34 917 90 42 medinfoEMEA@takeda.com Polska Takeda Pharma Sp. z o.o. Tel.: +48223062medinfoEMEA@takeda.com France Takeda France SAS T l: + 33 1 40 67 33 medinfoEMEA@takeda.com Portugal Takeda Farmac uticos Portugal, Lda. Tel: + 351 21 120 1medinfoEMEA@takeda.com Hrvatska Takeda Pharmaceuticals Croatia d.o.o. Tel: +385 1 377 88 medinfoEMEA@takeda.com Rom nia Takeda Pharmaceuticals SRL Tel: +40 21 335 03 medinfoEMEA@takeda.com Ireland Takeda Products Ireland Ltd Tel: 1800 937 medinfoEMEA@takeda.com Slovenija Takeda Pharmaceuticals farmacevtska dru ba d.o.o. Tel: + 386 (0) 59 082 medinfoEMEA@takeda.com sland Vistor hf. S mi: +354 535 7medinfoEMEA@takeda.com Slovensk republika Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20 602 medinfoEMEA@takeda.com Italia Takeda Italia S.p.A. Tel: +39 06 502medinfoEMEA@takeda.com Suomi/Finland Takeda Oy Puh/Tel: 0800 774 medinfoEMEA@takeda.com

A.POTAMITIS MEDICARE LTD : +357 22583a.potamitismedicare@cytanet.com.cy Sverige Takeda Pharma AB Tel: 020 795 medinfoEMEA@takeda.com Latvija Takeda Latvia SIA Tel: +371 67840medinfoEMEA@takeda.com United Kingdom (Northern Ireland) Takeda UK Ltd Tel: +44 (0) 2830 640 medinfoEMEA@takeda.com This leaflet was last revised in. Detailed information on this medicine is available on the European Medicines Agency web site: